UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012799 |
|---|---|
| Receipt number | R000014951 |
| Scientific Title | Examination of protective efficacy of influenza by zanamivir among the staff of a medical facility |
| Date of disclosure of the study information | 2014/01/09 |
| Last modified on | 2014/01/09 02:30:54 |
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Basic information
Public title
Examination of protective efficacy of influenza by zanamivir among the staff of a medical facility
Acronym
Protective efficacy by zanamivir in a medical facility
Scientific Title
Examination of protective efficacy of influenza by zanamivir among the staff of a medical facility
Scientific Title:Acronym
Protective efficacy by zanamivir in a medical facility
Region
| Japan |
Condition
Condition
influenza
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make sure whether zanamivir has protective efficacy among the staff in medical facilities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of influenza-like illness
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
prophylactic administration of zanamivir
Interventions/Control_2
administration of pracebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the staff who;
1.works in Shizuoka Kosei Hospital and collaboration facilities
2.works the day shift
3.gives written informed concent
Key exclusion criteria
the staff who;
1.has specific medical history
Ex.1 asthma
Ex.2 other pulmonary diseases
Ex.3 taking medications affecting immune system
2.shows difficulty in inhalation of zanamivir
3.is considered unsuitable by a responsibil doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Tanaka |
Organization
Shizuoka Kosei Hospital
Division name
Department of Pediatrics
Zip code
Address
23 Kitaban-cho, Aoi-ku, Shizuoka-city, Japan
TEL
054-271-7177
toshihiro.tanaka@alumni.utoronto.ca
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Tanaka |
Organization
Shizuoka Kosei Hospital
Division name
Department of Pediatrics
Zip code
Address
23 Kitaban-cho, Aoi-ku, Shizuoka-city, Japan
TEL
054-271-7177
Homepage URL
toshihiro.tanaka@alumni.utoronto.ca
Sponsor or person
Institute
Shizuoka Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Kosei Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
静岡厚生病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2013 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 09 | Day |
Last modified on
| 2014 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014951
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
